Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial (BIRCRMGILYCT)

July 20, 2022 updated by: Mansoura University

Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial

compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35111
        • Faculty of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)
  • vital teeth
  • no sensitivity to teeth percussion
  • no spontaneous pain
  • no radiolucency in the periapical or furcation area of teeth
  • complete and normal occlusion
  • good oral hygiene

Exclusion Criteria:

  • poor oral hygiene
  • severe or chronic periodontal problems
  • periapical lesions
  • heavy bruxism
  • non-vital teeth
  • visibly cracked teeth
  • spontaneous dental pain
  • sensitivity to teeth percussion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: ACTIVA bioactive
bioactive ionic resin composite
Other: ACTIVA bioactive
bioactive ionic resin composite
OTHER: Riva LC
Resin-modifed glass ionomer
Other: Riva LC
resin-modified glass ionomer
Other Names:
  • Riva light cure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria
Time Frame: 2-years
comparison of 2-year clinical performance of recent bioactive ionic resin composite( ACTIVA bioactive) to resin-modified glass ionomer liner ( Riva LC) in indirect dental pulp treatment using FDI world dental federation clinical criteria.
2-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: salah mahmoud, professor, Faculty of Dentistry, Mansoura university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2019

Primary Completion (ACTUAL)

October 30, 2021

Study Completion (ACTUAL)

December 20, 2021

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (ACTUAL)

July 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19091019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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